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ESOMEPRAZOLE 20 MG GASTRO RESISTANT TABLETS

Active substance(s): ESOMEPRAZOLE MAGNESIUM DIHYDRATE / ESOMEPRAZOLE MAGNESIUM DIHYDRATE

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Do not take Esomeprazole gastro-resistant tablets if you are taking a medicine containing
nelfinavir (used to treat HIV infection).

PACKAGE LEAFLET: INFORMATION FOR THE USER

Esomeprazole 20 mg gastro-resistant tablets
Esomeprazole 40 mg gastro-resistant tablets
esomeprazole
Read all of this leaflet carefully before you start taking this medicine because it
contains important information for you.
· Keep this leaflet. You may need to read it again.
· If you have any further questions, ask your doctor or pharmacist.
· This medicine has been prescribed for you only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same as yours.
· If you get any side effects, talk to your doctor or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Esomeprazole gastro-resistant tablets are and what they are used for
2. What you need to know before you take Esomeprazole gastro-resistant tablets
3. How to take Esomeprazole gastro-resistant tablets
4. Possible side effects
5. How to store Esomeprazole gastro-resistant tablets
6. Contents of the pack and other information
1. What Esomeprazole gastro-resistant tablets are and what they are used for
Esomeprazole gastro-resistant tablets contain a medicine called esomeprazole. This
belongs to a group of medicines called ‘proton pump inhibitors’. They work by reducing
the amount of acid that your stomach produces.
Esomeprazole gastro-resistant tablets are used to treat the following conditions:
Adults
· ‘Gastroesophageal reflux disease’ (GERD). This is where acid from the stomach
escapes into the gullet (the tube which connects your throat to your stomach) causing
pain, inflammation and heartburn.
· Ulcers in the stomach or upper part of the gut (intestine) that are infected with bacteria
called ‘Helicobacter pylori’. If you have this condition, your doctor may also prescribe
antibiotics to treat the infection and allow the ulcer to heal.
· Stomach ulcers caused by medicines called NSAIDs (Non-Steroidal AntiInflammatory Drugs). Esomeprazole gastro-resistant tablets can also be used to stop
stomach ulcers from forming if you are taking NSAIDs.
· Too much acid in the stomach caused by a growth in the pancreas (Zollinger-Ellison
syndrome).
· Prolonged treatment after prevention of rebleeding of ulcers with intravenous
esomeprazole.
Adolescents aged 12 years and above
· ‘Gastroesophageal reflux disease’ (GERD). This is where acid from the stomach
escapes into the gullet (the tube which connects your throat to your stomach) causing
pain, inflammation and heartburn.
· Ulcers in the stomach or upper part of the gut (intestine) that are infected with bacteria
called ‘Helicobacter pylori’. If you have this condition, your doctor may also prescribe
antibiotics to treat the infection and allow the ulcer to heal.
2. What you need to know before you take Esomeprazole gastro-resistant tablets
Do not take Esomeprazole gastro-resistant tablets if:
· You are allergic (hypersensitive) to esomeprazole or any of the other ingredients of this
medicine (listed in section 6).
· You are allergic to other proton pump inhibitor medicines (e.g. pantoprazole,
lanzoprazole, rabeprazole, omeprazole).
· You are taking a medicine containing nelfinavir (used to treat HIV infection).
Do not take Esomeprazole gastro-resistant tablets if any of the above apply to you. If you
are not sure, talk to your doctor or pharmacist before taking Esomeprazole gastro-resistant
tablets.
Warnings and precautions
Talk to your doctor or pharmacist before taking Esomeprazole gastro-resistant tablets if:
· You have severe liver problems.
· You have severe kidney problems.
· You have ever had a skin reaction after treatment with a medicine similar to
Esomeprazole gastro-resistant tablets.
Esomeprazole gastro-resistant tablets may hide the symptoms of other diseases.
Therefore, if any of the following happen to you before you start taking Esomeprazole
gastro-resistant tablets or while you are taking it, talk to your doctor straight away:
· You lose a lot of weight for no reason and have problems swallowing.
· You get stomach pain or indigestion.
· You begin to vomit food or blood.
· You pass black stools (blood-stained faeces).
If you have been prescribed Esomeprazole gastro-resistant tablets “on demand” you should
contact your doctor if your symptoms continue or change in character.
If you get a rash on your skin, especially in the areas exposed to the sun tell your doctor as
soon as you can, as you may need to stop your treatment with Esomeprazole gastroresistant tablets. Remember to also mention any other ill-effects like pain in your joints.
Taking a proton pump inhibitor like Esomeprazole gastro-resistant tablets, especially over
a period of more than one year, may slightly increase your risk of fracture in the hip, wrist or
spine. Tell your doctor if you have osteoporosis or if you are taking corticosteroids (which
can increase the risk of osteoporosis).
Children under the age of 12 years
Esomeprazole gastro-resistant tablets should not be used in children younger than 12 years.
More appropriate pharmaceutical forms of esomeprazole may be available.
Other medicines and Esomeprazole gastro-resistant tablets
Tell your doctor or pharmacist if you are taking, have recently taken or might take, any
other medicines. This includes medicines that you buy without a prescription. This is
because Esomeprazole gastro-resistant tablets can affect the way some medicines work and
some medicines can have an effect on Esomeprazole gastro-resistant tablets.

Tell your doctor or pharmacist if you are taking any of the following medicines:
· Atazanavir (used to treat HIV infection).
· Clopidogrel (used to prevent blood clots).
· Ketoconazole, itraconazole or voriconazole (used to treat infections caused by a
fungus).
· Erlotinib (used to treat cancer).
· Citalopram, imipramine or clomipramine (used to treat depression).
· Diazepam (used to treat anxiety, relax muscles or in epilepsy).
· Phenytoin (used in epilepsy). If you are taking phenytoin, your doctor will need to
monitor you when you start or stop taking Esomeprazole gastro-resistant tablets.
· Medicines that are used to thin your blood, such as warfarin. Your doctor may need to
monitor you when you start or stop taking Esomeprazole gastro-resistant tablets.
· Cilostazol (used to treat intermittent claudication – a pain in your legs when you walk
which is caused by an insufficient blood supply).
· Cisapride (used for indigestion and heartburn).
· Digoxin (used for heart problems).
· Methotrexate (a chemotherapy medicine used in high doses to treat cancer) – if you are
taking a high dose of methotrexate, your doctor may temporarily stop your
esomeprazole treatment.
· Tacrolimus (organ transplantation).
· Rifampicin (used for treatment of tuberculosis).
· St. John’s wort (Hypericum perforatum) (used to treat depression).
If your doctor has prescribed the antibiotics amoxicillin and clarithromycin as well as
Esomeprazole gastro-resistant tablets to treat ulcers caused by Helicobacter pylori
infection, it is very important that you tell your doctor about any other medicines you are
taking.
Esomeprazole gastro-resistant tablets with food and drink
You can take your tablets with food or on an empty stomach.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine. Your doctor will
decide whether you can take Esomeprazole gastro-resistant tablets during this time.
It is not known if esomeprazole passes into breast milk. Therefore, you should not take
Esomeprazole gastro-resistant tablets if you are breast-feeding.
Driving and using machines
Esomeprazole gastro-resistant tablets are not likely to affect you being able to drive or use
any tools or machines. However, side effects such as dizziness and blurred vision may
uncommonly or rarely occur (see section 4). If affected, you should not drive or use
machines.
Esomeprazole gastro-resistant tablets contain sucrose and lactose
Sucrose and lactose are types of sugar. If you have been told by your doctor that you have an
intolerance to some sugars, talk to your doctor before taking this medicine.
3. How to take Esomeprazole gastro-resistant tablets
Always take this medicine exactly as your doctor or pharmacist has told you. Check with
your doctor or pharmacist if you are not sure.
· If you are taking this medicine for a long time, your doctor will want to monitor you
(particularly if you are taking it for more than a year).
· If your doctor has told you to take this medicine as and when you need it, tell your
doctor if your symptoms change.
How much to take
· Your doctor will tell you how many tablets to take and how long to take them for. This
will depend on your condition, how old you are and how well your liver works.
· The recommended doses are given below.
Adults aged 18 and above
To treat heartburn caused by gastroesophageal reflux disease (GERD):
- If your doctor has found that your food pipe (gullet) has been slightly damaged, the
recommended dose is one Esomeprazole 40 mg gastro-resistant tablet once a day for 4
weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your
gullet has not yet healed.
- The recommended dose once the gullet has healed is one Esomeprazole 20 mg gastroresistant tablet once a day.
- If your gullet has not been damaged, the recommended dose is one Esomeprazole 20
mg gastro-resistant tablet each day. Once the condition has been controlled, your
doctor may tell you to take your medicine as and when you need it, up to a maximum of
one Esomeprazole 20 mg gastro-resistant tablet each day.
- If you have severe liver problems, your doctor may give you a lower dose.
To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
- The recommended dose is one Esomeprazole 20 mg gastro-resistant tablet twice a day
for one week.
- Your doctor will also tell you to take antibiotics for example amoxicillin and
clarithromycin.
To treat stomach ulcers caused by NSAIDs (Non-Steroidal Anti-Inflammatory
Drugs):
- The recommended dose is one Esomeprazole 20 mg gastro-resistant tablet once a day
for 4 to 8 weeks.
To prevent stomach ulcers if you are taking NSAIDs (Non-Steroidal AntiInflammatory Drugs):
- The recommended dose is one Esomeprazole 20 mg gastro-resistant tablet once a day.
To treat too much acid in the stomach caused by a growth in the pancreas (ZollingerEllison syndrome):
- The recommended dose is one Esomeprazole 40 mg gastro-resistant tablet twice a day.
- Your doctor will adjust the dose depending on your needs and will also decide how long
you need to take the medicine for. The maximum dose is 80 mg twice a day.
Prolonged treatment after prevention of rebleeding of ulcers with intravenous
esomeprazole:
- The recommended dose is one Esomeprazole 40 mg gastro-resistant tablet once a day
for 4 weeks.

Code

AW.CRC.118.03.V03

1

Grasshopper Sistemas de Informação
geral@gsiportugal.com
www.gsiportugal.com

Customer

Date

2016-09-13

Description

ESOMEPRAZOLE 20mg and 40mg
GASTRO-RESISTANT TABLETS
(Package leaflet EN)
Size

240x420mm

Pantone:
Black
Keyline

Colours

Notes

NO GOOD FOR COLOR PROOF

Adolescents aged 12 or above
To treat heartburn caused by gastroesophageal reflux disease (GERD):
- If your doctor has found that your food pipe (gullet) has been slightly damaged, the
recommended dose is one Esomeprazole 40 mg gastro-resistant tablet once a day for 4
weeks. Your doctor may tell you to take the same dose for a further 4 weeks if your
gullet has not yet healed.
- The recommended dose once the gullet has healed is one Esomeprazole 20 mg gastroresistant tablet once a day
- If your gullet has not been damaged, the recommended dose is one Esomeprazole 20
mg gastro-resistant tablet each day.
- If you have severe liver problems, your doctor may give you a lower dose.
To treat ulcers caused by Helicobacter pylori infection and to stop them coming back:
- The recommended dose is one Esomeprazole 20 mg gastro-resistant tablet twice a day
for one week.
- Your doctor will also tell you to take antibiotics for example amoxicillin and
clarithromycin.
Taking this medicine
· You can take your tablets at any time of the day.
· You can take your tablets with food or on an empty stomach.
· Swallow your tablets whole with a drink of water. Do not chew or crush the tablets. This
is because the tablets contain coated pellets which stop the medicine from being broken
down by the acid in your stomach. It is important not to damage the pellets.
What to do if you have trouble swallowing the tablets
· If you have trouble swallowing the tablets:
- Put them into a glass of still (non-fizzy) water. Do not use any other liquids.
- Stir until the tablets break up (the mixture will not be clear). Then drink the mixture
straight away or within 30 minutes.Always stir the mixture just before drinking it.
- To make sure that you have drunk all of the medicine, rinse the glass very well with
half a glass of water and drink it. The solid pieces contain the medicine - do not
chew or crush them.
· If you cannot swallow at all, the tablet can be mixed with some water and put into a
syringe. It can then be given to you through a tube directly into your stomach (‘gastric
tube’).
Children under the age of 12 years
Esomeprazole gastro-resistant tablets are not recommended for children less than 12 years
old.

· Joint pains (arthralgia) or muscle pains (myalgia).
· Generally feeling unwell and lacking energy.
· Increased sweating.
Very rare (may affect up to 1 in 10000 people)
· Changes in blood count including agranulocytosis (lack of white blood cells).
· Aggression.
· Seeing, feeling or hearing things that are not there (hallucinations).
· Severe liver problems leading to liver failure and inflammation of the brain.
· Sudden onset of a severe rash or blistering or peeling skin. This may be associated with
a high fever and joint pains (Erythema multiforme, Stevens-Johnson syndrome, toxic
epidermal necrolysis).
· Muscle weakness.
· Severe kidney problems.
· Enlarged breasts in men.
Not known (frequency cannot be estimated from the available data)
· If you are on Esomeprazole gastro-resistant tablets for more than three months it is
possible that the levels of magnesium in your blood may fall. Low levels of magnesium
can be seen as fatigue, involuntary muscle contractions, disorientation, convulsions,
dizziness or increased heart rate. If you get any of these symptoms, please tell your
doctor promptly. Low levels of magnesium can also lead to a reduction in potassium or
calcium levels in the blood. Your doctor may decide to perform regular blood tests to
monitor your levels of magnesium.
· Inflammation in the gut (leading to diarrhoea).
· Rash, possibly with pain in the joints.
Esomeprazole gastro-resistant tablets may in very rare cases affect the white blood cells
leading to immune deficiency. If you have an infection with symptoms such as fever with a
severely reduced general condition or fever with symptoms of a local infection such as pain
in the neck, throat or mouth or difficulties in urinating, you must consult your doctor as
soon as possible so that a lack of white blood cells (agranulocytosis) can be ruled out by a
blood test. It is important for you to give information about your medication at this time.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Scheme (website: www.mhra.gov.uk/yellowcard). By reporting side effects
you can help provide more information on the safety of this medicine.
5. How to store Esomeprazole gastro-resistant tablets

Older people
Dose adjustment is not required in the elderly.
If you take more Esomeprazole gastro-resistant tablets than you should
If you take more Esomeprazole gastro-resistant tablets than prescribed by your doctor, talk
to your doctor or pharmacist straight away.
If you forget to take Esomeprazole gastro-resistant tablets
· If you forget to take a dose, take it as soon as you remember it. However, if it is almost
time for your next dose, skip the missed dose.
· Do not take a double dose (two doses at the same time) to make up for a forgotten dose.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you notice any of the following serious side effects, stop taking Esomeprazole
gastro-resistant tablets and contact a doctor immediately:
· Sudden wheezing, swelling of your lips, tongue and throat or body, rash, fainting or
difficulties in swallowing (severe allergic reaction).
· Reddening of the skin with blisters or peeling. There may also be severe blisters and
bleeding in the lips, eyes, mouth, nose and genitals. This could be ‘Stevens-Johnson
syndrome’or ‘toxic epidermal necrolysis’.
· Yellow skin, dark urine and tiredness which can be symptoms of liver problems.
These effects are rare and may affect up to 1 in 1000 people.
Other side effects include:
Common (may affect up to 1 in 10 people)
· Headache.
· Effects on your stomach or gut: diarrhoea, stomach pain, constipation, wind
(flatulence).
· Feeling sick (nausea) or being sick (vomiting).
Uncommon (may affect up to 1 in 100 people)
· Swelling of the feet and ankles.
· Disturbed sleep (insomnia).
· Dizziness, tingling feelings such as “pins and needles”, feeling sleepy.
· Spinning feeling (vertigo).
· Dry mouth.
· Changes in blood tests that check how the liver is working.
· Skin rash, lumpy rash (hives) and itchy skin.
· Fracture of the hip, wrist or spine (if Esomeprazole gastro-resistant tablets are used in
high doses and over long duration).
Rare (may affect up to 1 in 1000 people)
· Blood problems such as a reduced number of white cells or platelets. This can cause
weakness, bruising or make infections more likely.
· Low levels of sodium in the blood. This may cause weakness, being sick (vomiting)
and cramps.
· Feeling agitated, confused or depressed.
· Taste changes.
· Eyesight problems such as blurred vision.
· Suddenly feeling wheezy or short of breath (bronchospasm).
· An inflammation of the inside of the mouth.
· An infection called “thrush” which can affect the gut and is caused by a fungus.
· Liver problems, including jaundice which can cause yellow skin, dark urine, and
tiredness.
· Hair loss (alopecia).
· Skin rash on exposure to sunshine.

· Keep this medicine out of the sight and reach of children.
· Store below 25°C.
· Keep this medicine in the original package or keep the bottle tightly closed to protect
from moisture.
· Do not use this medicine after the expiry date which is stated on the blister, bottle and
carton after EXP. The expiry date refers to the last day of that month.
· Do not throw away any medicines via wastewater or household waste. Ask your
pharmacist how to throw away medicines you no longer use. These measures will help
to protect the environment.
6. Contents of the pack and other information
What Esomeprazole gastro-resistant tablets contains
The active substance is esomeprazole. Esomeprazole gastro-resistant tablets come in two
strengths containing 20 mg or 40 mg of esomeprazole (as magnesium salt).
The other ingredients are sucrose, maize starch, hydroxypropylcellulose (E463),
crospovidone (E1202), hydroxypropyl methylcellulose (E464), magnesium oxide, talc
(E553b), macrogol, polysorbate 80 (E433), glycerol monostearate (E471), methacrylic
acid ethyl acrylate copolymer dispersion 30 percent, hypromellose phthalate,
microcrystalline cellulose (E460), ferric oxide red (E172), ferric oxide yellow (E172) (only
for the 20 mg), povidone (E1201), pregelatinized starch, colloidal hydrated silica, titanium
dioxide (E171), lactose monohydrate.
What Esomeprazole gastro-resistant tablets look like and contents of the pack
· Esomeprazole 20 mg gastro-resistant tablets are light pink coloured, oblong, biconvex,
coated tablets debossed with 20 on one side and CE on the other.
· Esomeprazole 40 mg gastro-resistant tablets are pink coloured, oblong, biconvex,
coated tablets debossed with 40 on one side and CE on the other.
· Your tablets will come in bottles or blister packs:
- bottles of 14, 15, 28, 30, 56, 60, 100 or 140 tablets (20 mg) and bottles of 14, 15, 28,
30, 56 or 60 tablets (40 mg).
- blister packs in cartons of 7, 14, 28, 30, 50, 56, 60, 90, 98, 100 or 140 tablets.
Not all pack sizes may be marketed.
MarketingAuthorisation Holder and Manufacturer
MarketingAuthorisation Holder
Jubilant Pharmaceuticals nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium
Manufacturer
PSI supply nv
Axxes Business Park
Guldensporenpark 22 – Block C
9820 Merelbeke
Belgium
Distributor
Crescent Pharma Ltd,
Units 3 & 4, Quidhampton Business Units,
Polhampton Lane, Overton,
Hampshire RG25 3ED
United Kingdom
This leaflet was last revised in 08/2016.

Code

2

AW.CRC.118.03.V03

Grasshopper Sistemas de Informação
geral@gsiportugal.com
www.gsiportugal.com

Customer

Date

2016-09-13

Description

ESOMEPRAZOLE 20mg and 40mg
GASTRO-RESISTANT TABLETS
(Package leaflet EN)
Size

240x420mm

Pantone:
Black
Keyline

Colours

Notes

NO GOOD FOR COLOR PROOF

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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